High Throughput Fractionation and Concentration System for MALDI-MS This Small Business Innovative Research (SBIR) Phase II project aims to build upon the successful work completed in the Phase I feasibility study to optimize and construct a prototype system for the preparation of up to 96 serum samples in parallel for matrix assisted laser desorption ionization (MALDI) mass spectrometry (MS). This system, called the MALDIplex(tm) M5 Sample Prep Station, consists of a benchtop instrument, a graphical user interface (GUI), and single-use 96-well cartridges. The MALDIplex cartridges are specially designed to permit parallel vertical separation from each well through a series of stacked thin layer supports. The system permits integrated sample purification, fractionation, concentration, and desalting - all in a single, easy to use cartridge. Using this system, samples may be prepared simulaneously in less than 45 minutes. No other system offers the potential throughput and data quality achievable with this system. Phase II efforts will focus on the further development and optimization of quantitation and fractionation protocols, as well as improved system designs (for automation) and methods for protein identification from the cartridge surface. This innovative technology has the potential to play a key role in improving the understanding, diagnosis, prognosis, and treatment of complex disease such as cancer. If successful, the Phase II will result in an optimized sample preparation system ready for full scale manufacturing and commercialization in Phase III. 7. Project Narrative High Throughput Fractionation and Concentration System for MALDI-MS The search of novel drug targets and disease markers (biomarkers) using mass spectrometry holds tremendous potential for improving the understanding, diagnosis, prognosis, and treatment of disease. Many complex, life threatening diseases, such as cancer, require early diagnosis to maximize effective treatment. If successful, this Phase II research project will enable large scale, clinically-relevant biomarker discovery using mass spectrometry, which has the potential of revealing new, highly sensitive biomarkers for early disease diagnosis and to predict treatment response. [unreadable] [unreadable] [unreadable]